Miele PG 8527, PG 8528 Operating instructions

Operating instructions

Washer-disinfector PG 8527 / PG 8528

To avoid the risk of accidents or damage to the machine it is essential to read these instructions before it is installed, commissioned and used for the first time.

en - GB, AU, NZ

M.-Nr. 07 776 940

Contents

Warning and safety instructions .....................................5

Correct application ...............................................5

Using accessories ...............................................9

Symbols on the appliance .........................................9

Disposing of your old machine......................................9

Intended Use ....................................................10

Guide to the machine .............................................12

Controls .........................................................15

Display ..........................................................17

An example of a selected list ......................................17

An example of a programme sequence display .......................18

Context menu ....................................................19

Change display language ...........................................20

Changing operating level ...........................................21

Delay start .......................................................23

Switch heating method .............................................25

Current faults .....................................................25

Load items .......................................................25

Automatic mobile unit recognition...................................26

Areas of application...............................................27

Protein test .......................................................27

Loading the machine ...............................................28

Surgical instruments (OP) ...........................................29

Ophthalmology ...................................................30

Anaesthetic instruments (AN) ........................................31

Baby bottles (BC) .................................................32

Operating theatre shoes (OS) ........................................33

Laboratory glassware (LG) ..........................................34

Chemical processes and technology.................................35

Dispensing liquid chemical agents ..................................40

Dispensing systems................................................42

"Fill DOX [X] container" message ...................................42

Fill the containers with the relevant agent ............................42

"Check dispensing system [X]".....................................43

Venting the dispensing system.....................................43

Contents

Operation .......................................................44

Master switch.....................................................44

Switching on .....................................................44

Starting the programme.............................................45

Programme sequence ..............................................47

At the end of a programme ..........................................47

Switching off .....................................................47

Cancelling a programme ............................................47

Interrupting a programme ...........................................48

Barcode scanner (optional) ........................................49

Barcode scanner functions ..........................................49

Scanning the barcode with a conveyor system connected ...............50

Scan loading operator ..............................................51

To cancel Scan loading operator ...................................51

Scan unloading operator ............................................52

Skipping Scan unloading operator..................................52

Scanning the load .................................................53

Cancelling "Scan the load" ........................................54

Skipping "Scan the load"..........................................54

Accept Scanned loads ...........................................54

Scanned loads....................................................56

Adding scanned loads ...........................................57

Displaying scanned loads ........................................58

Deleting scanned loads ..........................................59

Moving scanned loads ...........................................60

Data transfer.....................................................61

Maintenance .....................................................62

Periodic checks ...................................................62

Process validation .................................................63

Routine checks ...................................................63

Cleaning the filters in the wash cabinet.................................64

Cleaning the fine filter............................................64

Cleaning the flat filter ............................................64

Cleaning the filters for the circulation pump...........................65

Cleaning the spray arms ............................................66

Cleaning the controls and the (optional) glass door .......................67

Contents

Cleaning the front of the machine .....................................67

Cleaning the wash cabinet ..........................................67

Cleaning the door seals.............................................67

Mobile units, modules and inserts .....................................68

Integrated printer (optional)..........................................69

Renewing the paper roll ..........................................69

Renewing the ribbon.............................................69

After sales service ................................................70

Electrical connection .............................................71

Plumbing........................................................72

Technical data ...................................................73

Optional extras...................................................74

Special processes - OXIVARIO and ORTHOVARIO .....................75

Description of the machine ..........................................75

Areas of application .............................................75

Warning and Safety instructions ......................................76

Connecting the H

Disposal of your old machine.......................................77

solution container ................................76

2O2

Warning and safety instructions

This machine complies with all relevant local and national safety requirements. Please note that incorrect use can lead to personal injury and damage to property. To avoid the risk of accidents and damage to the machine, please read these instructions carefully before starting to use it. Keep these instructions in a safe place for reference, and pass them on to any future user.

Correct application

This washer-disinfector is designed

for use with the applications described in these Operating Instructions only. Alterations or conversions to the machine, or using it for purposes other than those for which it was designed, are not permitted and could be dangerous. This machine must only be used for cleaning and disinfecting instruments, medical devices and laboratory equipment if the manufacturer has stated that they are suitable for machine processing. Manufacturer's cleaning and maintenance instructions for instruments etc. must also be observed. Miele cannot be held liable for damage caused by improper or incorrect use or operation of the machine.

This machine is intended for indoor

use only.

This machine is not designed for

use in mobile installations unless a risk assessment of the installation has been carried out by a suitably qualified engineer.

Please pay attention to the following notes to avoid injury and damage.

This machine should be

commissioned and then maintained by a Miele authorised and trained service technician only. A Miele service contract is recommended to ensure compliance with GLP Guidelines and the Medical Devices Directive. Unauthorised repairs could be dangerous, for which the manufacturer cannot be held liable.

Do not install the machine in an area

where there is any danger of explosion or of freezing conditions.

The electrical safety of this machine

can only be guaranteed if connected to a correctly installed earthing system on site. It is most important that this basic safety requirement is present and regularly tested, and where there is any doubt the on-site wiring system should be inspected by a qualified electrician. The manufacturer cannot be held liable for damage or injury caused by the lack of or inadequacy of an effective earthing system (e.g. electric shock).

A damaged or leaking machine

could be dangerous and compromise your safety. Disconnect the machine from the mains immediately and call the Miele Service Department.

Warning and safety instructions

Personnel operating the machine

should be trained regularly. Untrained personnel must not be allowed access to the machine or its controls.

Take care when handling chemical

agents such as cleaning agent, neutralising agent, rinsing agent etc. These may contain irritant or corrosive ingredients. Please follow the manufacturer's safety instructions. Wear protective gloves and goggles. With all chemical agents, the manufacturer's safety instructions and safety data sheets must be observed.

The machine is designed for

operation with water and recommended additive chemical agents only. Organic solvents and flammable liquid agents must not be used in this machine. These could cause an explosion, damage rubber and plastic components in the machine, and cause liquids to leak out of the machine.

The water in the cabinet must not be

used as drinking water.

Be careful when sorting items with

sharp pointed ends and positioning them in the machine that you do not hurt yourself or create a danger for others. Sharp knives etc. should be placed in baskets with the pointed ends facing downwards.

When using this machine in the

higher temperature ranges, be especially careful not to scald or burn yourself or come into contact with irritant substances when opening the door. Where disinfecting agents are used there is a danger of inhaling toxic vapours.

Where there is a risk of toxic or

chemical substances occuring in the suds solution (e.g. aldehyde in the disinfecting agent), it is essential to regularly check door seals and make sure that the steam condensor is functioning correctly. Opening the machine door during a programme interruption carries particular risks in such circumstances.

Should personnel accidentally come

into contact with toxic vapours or chemical agents, follow the emergency instructions given in the manufacturer's safety data sheets.

Mobile units, modules, inserts and

the load must be allowed to cool down before they are unloaded. Any water remaining in containers could still be very hot. Empty them into the wash cabinet before taking them out.

After using the hot air drying unit,

open the door to allow the everything in the cabinet from the load itself to the mobile units, modules and inserts to cool down.

Warning and safety instructions

If the boiler has been programmed

to "BOILER READY", be particularly careful of hot water and steam when opening the door. Danger of burning or scalding. The inlet to the wash cabinet is located, as viewed from the unclean side, underneath the basket runner on the right hand side.

Steam heating is permissible up to a

pressure of 1000 kPa (10 bar). This corresponds to a water steam temperature of 179°C.

Never clean the machine or near

vicinity with a hose or a pressure washer.

The machine must be disconnected

from the mains electricity supply before any maintenance or repair work is carried out. Do not reconnect it until the maintenance or repair work has been successfully completed.

The following points should be observed to assist in maintaining quality standards for processing medical devices and sensitive laboratory glassware, and to avoid injury to patients or damage to equipment.

If the machine is being used for

disinfection in accordance with official regulations on the control of epidemics, the steam condenser and its connections to and from the wash cabinet must be cleaned and disinfected whenever any repairs are carried out or parts replaced.

If it is necessary to interrupt a

programme in exceptional circumstances, this may only be done by authorised personnel.

The standard of cleaning and

disinfection in the disinfection programmes must be routinely confirmed by the user. The process should be validated on a regular basis, and checked against documented control results. Chemical disinfection procedures should also be validated using chemical or bio indicators.

For thermal disinfection, use

temperatures and temperature holding times to achieve the required infection prophylaxis in accordance with current health and safety regulations.

Disinfection programmes which use

a chemical disinfecting agent at moderate temperatures such as 65 °C or lower are not recognised by §18 IfSG for disinfection. They should only be used for items which cannot withstand the higher temperatures used by thermal disinfection. The range of effective disinfection is based on claims made by the producer of the disinfecting agent. Their instructions on handling, use and effectiveness must be observed. The use of chemical disinfection procedures is the responsibility of the operator.

Theatre (OP) shoes should only be

cleaned and disinfected in a machine installed specifically for this purpose.

Warning and safety instructions

Only use chemical agents

formulated for special processes and approved by Miele for use with this machine. Use of unsuitable agents could adversely affect the components of the machine. In the event of any damage or material deterioration please contact your Miele application specialist.

Pre-treatments with cleaning or

disinfecting agents can create foam, as can certain types of soiling and chemical agents. Foam can have an adverse effect on the disinfection and cleaning result.

Foam must not be able to escape

from the wash cabinet. It would hinder the correct functioning of the machine.

Check the process used regularly to

monitor foaming levels.

To avoid the risk of damage to the

machine and any accessories used with it caused by chemical agents, soiling and any reaction between the two please read the notes in "Chemical Processes and Technology".

Where a chemical agent is

recommended on technical application grounds (e.g. a cleaning agent), this does not imply that the manufacturer of the machine accepts liability for the effect of the chemical on the items being cleaned. Please be aware that changes in formulation, storage conditions etc. which may not be publicised by the chemical manufacturer, can have a negative effect on the cleaning result.

When using cleaning agents and

specialised products it is essential that the manufacturer's instructions are followed. Only use the product for the application described by the manufacturer, to avoid any material damage or the occurrence of strong chemical reactions.

In critical applications where very

stringent requirements have to be met, it is strongly recommended that all the relevant factors for the process, such as chemical agents, water quality etc. are discussed with the Miele Application Technology specialists.

If cleaning and rinsing results are

subject to particularly stringent requirements (e.g. chemical analysis, specialised industrial processes etc.), a regular quality control test must be carried out by the user to ensure that the required standards of cleanliness are being achieved.

Mobile units, modules and inserts

should only be used for the purpose they are designed for. Hollow instruments must be thoroughly cleaned, internally and externally.

Empty any containers or utensils

before arranging them in the machine.

Do not allow any remains of acids or

solvents, and in particular hydrochloric acid or chloride solutions, to get into the wash cabinet. Similarly avoid any materials with a corrosive effect. The presence in compounds of any solvents should be minimal (especially those in hazard class A1).

Warning and safety instructions

Ensure that solutions or steam

containing hydrochloric acid do not come into contact with the steel outer casing of the machine, to avoid any corrosion damage.

After carrying out any work on the

mains water system, the water supply system to the washer-disinfector must be vented. Otherwise, the components in the machine may become damaged.

Please follow the advice on

installation in these instructions and the separate Installation Instructions.

Using accessories

Only use genuine Miele original

accessories with this machine. Consult Miele on the type and application of such equipment.

Only use Miele mobile units,

modules and inserts in this machine. Using accessories made by other manufacturers, or making modifications to Miele accessories, can result in unsatisfactory cleaning and disinfecting results, for which Miele cannot be held liable. Any resultant damage would also invalidate the machine guarantee.

Only use chemical agents which

have been approved by their manufacturer for use in the application you are using. The chemical agent manufacturer is responsible for any negative influences on the material the load is made from and for any damage they may cause to the machine.

Symbols on the appliance

Warning: Observe the operating instructions.

Warning: Danger of electric shock.

Disposing of your old machine

Please note that the machine may

have contamination from blood or other bodily fluids in it and must be decontaminated before disposal. For environmental and safety reasons ensure the machine is completely drained of any residual water, chemical residues and cleaning agent. Observe safety regulations and wear safety goggles and gloves. Make the door lock inoperative, and block or disable the door in such a way that children cannot accidentally shut themselves in the cabinet. Then make appropriate arrangements for the safe disposal of the appliance. For tank system machines ensure that any water is emptied out of the tank before it is moved.

The manufacturer cannot be held liable for damage caused by non-compliance with these Warning and Safety instructions.

Intended Use

This washer-disinfector can be used to clean, rinse, disinfect (thermally and chemically) and dry a wide range of reusable medical devices and laboratory equipment. Follow the manufacturer's instructions (according to EN ISO 17664) on how to process their items by machine.

Examples of application areas:

surgical instruments,

–

minimally invasive surgical

–

instruments,

– anaesthetic and intensive care

instruments,

– baby bottles and teats,

– maintenance and waste containers,

– operating theatre shoes,

– laboratory equipment used in

research and development,

–

laboratory equipment used in areas of analysis and specimen taking,

–

laboratory equipment used in micro-biology and biotechnology.

The type of laboratory equipment which can be processed ranges from evaporating dishes to centrifugal test tubes.

Processing medical devices and laboratory equipment by machine achieves reproducible results, and should be used in preference to processing them by hand. Where disinfection is required for the protection of staff and/or patients, a thermal disinfection programme, e.g. the DESIN vario TD programme, should be selected. The parameters for thermal disinfection according to EN ISO 15883-1 (A

concept) vary depending on the disinfection standard required. They are 80 °C (+ 5 °C, - 0 °C) with a 10 min holding time (A

- 0 °C) with a 5 min holding time (A

600) or 90 °C (+ 5 °C,

3000). An A0value of 3000 is suitable for deactivating the HBV virus.

National health and safety regulations regarding disinfection must also be observed.

The cleaning programme as well as any chemical agents must be chosen according to the type of soiling and load being processed. The agents used for processing the products should be selected to suit the level of cleaning required as well as the method of analysis used.

The cleaning result must ensure that instruments can be disinfected correctly, that no residues are left behind, that subsequent sterilisation can be carried out and that the instruments can be used again safely. Medical devices are best processed using the DESIN vario TD programme, or the ORTHOVARIO or OXIVARIO programme where applicable.

The use of a suitable carrier (mobile unit, module, insert etc.) is important to ensure the adequate cleaning of instruments and medical devices. Examples are given in the section "Areas of application".

The washer-disinfector is programmed to carry out the final rinse with mains water or prepared water (e.g. Aqua destillata, pure water, de-ionised water, demineralised water in the quality required by the application). The water quality is of particular importance for applications requiring analytically clean laboratory glassware.

Intended Use

The machine qualifies for the validating of processes in accordance with EN ISO 15883.

Guide to the machine

Unclean side

a Housing for hot air drying unit TA

and / or steam condenser DK

b "Profitronic" electronic controls (see

also "Programming manual")

c Multiport

d Master switch

e Scanner holder (optional)

f Service panel

g Docking facility for Transfer trolley

MF 27/28

h Door shown closed

Unclean side

Guide to the machine

a Door shown open

b Docking facility for mobile units and

modules

c Lower spray arm

d Filter combination

e Containers for dispensing systems

DOS 1 - DOS 4

Guide to the machine

Clean side (PG 8528 only)

a Door shown closed

b Service panel with docking facility for

Transfer trolley MF 27/28

c Multiport

d Scanner holder (optional)

e Printer (optional)

f Door release

g Display

Controls

Guide to the machine

a On/Off button s

For switching the machine on and off

b a Door release button

For opening and closing the door

c Display

The display will switch off automatically after approximately 10 minutes when the washer-disinfector is not in operation.

Press any button to switch the display back on again.

Faults occurring during operation will be indicated by a number in the display. The fault numbers are listed in the Programming manual.

Guide to the machine

d PC service interface 9

For testing and updating the programme data

e h Start button

For starting the programme

f +C (Clear) button used to

– return to the previous level – delete entries already made – cancel a programme

g and i - e buttons (Selector buttons) used to

– move the highlighting in the display – change highlighted values – scroll – call up context menus – show user defined operating parameters during the

programme

h OK button used to

- confirm highlighted options or selected values – acknowledge fault messages, – acknowledge dialogue messages, – call up the A

graph during the programme.

Display

The display can show the following, depending on the operating level:

the programme / programme overview

–

the programming menu

–

the Settings J menu

–

The Settings menu J is used to alter the washer-disinfector's profitronic controls to suit different requirements. See the Programming manual for more details.

An example of a selected list

Programme overview B

CHANGE-TA-FINE

DES-VAR-TD

DES-VAR-TD-AN

The -ebuttons are used to select the options.

Guide to the machine

The selector buttons -e move the highlighting in the display.

The OK button is used to confirm a message or setting and also to move to the next menu or to another menu level.

To select an option use the selector buttons -e to highlight it and then confirm your selection with the OK button.

The display shows a maximum of three options or choices. A scroll bar on the right hand side of the display indicates that more options or choices are available. The -e selector buttons are used to display these.

The end of the list is marked with a dotted line. The last entry in the list is shown above the line and the first, below it.

Guide to the machine

An example of a programme sequence display

DES-VAR-TD A Main wash 55.2 °C

During a programme, the display shows the following:

the name of the programme

–

the operating level

–

the programme block

–

the water temperature

–

(the air temperature in the "Drying" programme block)

– the estimated programme duration remaining or the

programme duration already elapsed

– any relevant fault messages and notes.

Time remaining 0:35 h

Context menu

Some functions can be called up at any time via a context menu, irrespective of the operating level:

Change display language,

–

Change operating level,

–

Enter delay start,

–

(On convertible washer-disinfectors)

–

Switch heating method,

Link the load items with the barcode scanner.

–

In addition, current fault messages will be displayed in operating level D (if applicable).

^ Press the - e buttons at the same time for at least 3

seconds to call up the context menu.

The context menu will appear in the display:

Context menu B

Scanned loads

Change display language F

Change operating level

The -ebuttons are used to select the options.

Context menu

Change display language

You can change the language in which the display is currently being shown via the context menu. The display will be shown in this new language until the washer-disinfector is switched off with the s button or the master switch.

N.B. The language which has been set in the Settings / Language J menu will not be changed and all reports and print-outs will continue to be printed in this "Settings" language.

Select the

activate your selection with OK.

The flag J after the words Change display language acts as a guide if a language which you do not understand has already been set. If this is the case, keep changing the options until the flag

J appears.

^ Select the language you require and confirm your selection

with OK.

The language selected will be shown in the display.

Press +C to come out of the context menu.

Change display language option with - e and

Changing operating level

There are four operating levels available on this washer-disinfector:

Operating level Access authorisation for

A and B Selection from a list of specified

C Automatic programme selection via mobile

D Free programme selection in the

You can switch between the operating levels via the context menu. To prevent unauthorised access to the settings, you will be asked for a code when changing to another operating level.

You must be signed on as the administrator, to be able to change the codes of the various operators or set up new operators. technician.

Context menu

programmes.

unit coding.

Programme overview, Programming and Settings J.

Administrator rights are set by a Miele Service

Press the - e buttons at the same time for at least 3 seconds.

The context menu will appear in the display:

Context menu B

Scanned loads

Change display language F

Change operating level

Context menu

Select the

Change operating level option and call up the

sub-menu with OK.

Select operator B

Operator ABC

Administrator Miele Service

Select the user group you require and confirm with OK.

Enter the requested code.

Change operating level B

0 FFF

Enter code

The -ebuttons alter the values, the OK button confirms the values entered and moves on to the next entry position.

The electronics will change to the operating level selected.

^ Press +C to come out of the context menu.

Code invalid will appear if you make a mistake.

Acknowledge the fault message with OK.

Start the Change operating level process again.

Delay start

Context menu

A programme can be set to start at a later, specific time.

To do this, highlight the

Delay start option and confirm

your selection.

To activate Delay start, select

Delay start

Activate Yes

Delay start

To set the Delay start time, highlight the

Yes for the Activate option.

Delay start

parameter and confirm your selection.

The menu for entering the start time will appear.

Delay start

17:48

Enter time

^ Enter the start time, digit by digit and confirm your entry.

Press the +C button repeatedly until the appears.

Main menu

Call up the

Programme overview B

CHANGE-TA-FINE

DES-VAR-TD

DES-VAR-TD-AN

Select a programme and start it with the h button.

Programme overview to select a programme.

Context menu

The selected programme, the start time set, the current time of day and time remaining until the start of the programme will appear in the display.

DES-VAR-TD Start time 17:15

Time remaining 01:55 h

15:20

The programme selected will now start automatically when the start time is reached.

The automatic start time for the programme can be cancelled.

^ Press the +C button.

An "Are you sure" question will appear:

Cancel start time?

Yes No

To cancel the programme start time, select

Yes and

confirm your selection.

The automatic start time for the programme is now cancelled. The display will change back to the Programme overview. The If you select

Delay start function is deactivated.

No the delay start time for the programme will

continue to count down.

Delay start function is deactivated automatically at

The the end of the programme.

You can also deactivate the

Delay start function without

actually starting the programme (starting the count down to the start time). To do this, set the

Delay start menu to No.

Activate parameter in the

+ 56 hidden pages

Miele PG 8527, PG 8528 Operating instructions

Specifications and Main Features

Frequently Asked Questions

User Manual